Ortho Clinical Diagnostics recalls VITROS Anti-SARS-CoV-2 Total Reagent (COV2TOT) due to potential false negatives or delayed results from swapped bottles. Affected lots 0010-0037.
The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures.
Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 Total Reagent (COV2TOT) because bottles may be swapped within the reagent pack, causing false negative results or delayed testing. This could lead to incorrect health assessments if used in diagnostic tests.
The reagent bottles might be swapped within the reagent pack, leading to calibration failures or quality control issues. This can cause false negative results or delayed test outcomes, potentially affecting accurate SARS-CoV-2 testing.
Laboratory professionals and healthcare facilities using the VITROS Anti-SARS-CoV-2 Total Reagent (COV2TOT) for in vitro diagnostics. Those using the affected lots (0010-0037) are most at risk.
Check the lot number on the reagent pack. Affected lots are 0010 through 0037. The product is labeled as VITROS Anti-SARS-CoV-2 Total Reagent (COV2TOT) with catalog number 6199922.
Verify the lot number on the reagent pack; affected lots are 0010-0037.
VITROS Anti-SARS-CoV-2 Total Reagent (COV2TOT) with catalog number 6199922.
Swapped bottles may cause false negative results or delayed test outcomes, potentially affecting accurate SARS-CoV-2 testing.
Check the lot number on the reagent pack; affected lots are 0010 through 0037.
We’ve drafted a message you can send Ortho Clinical Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-2770-2020 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-2770-2020 from Ortho Clinical Diagnostics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
